The Risk Based Monitoring Feedback Loop

This will be an interactive session during which we will go through the full journey of the risk signal communication and share our experiences and challenges. We will walk through the full cycle of the process including identification of key players and messages.

We will explore the impact of root cause analysis, the difference between risks and issues, and documentation practices. The session will cover examples of the risk signal responses from the angle of inspection readiness, and deciding ‘who’ will be ultimately responsible for closing the communication loop and ‘when’.

Catch up here!

This Community Forum took place on 21 February 2024. Catch up by viewing the recording.

Presenter

Bio

Vera Pomerantseva, ZS Associates

Vera Pomerantseva is Associate Partner, Risk and Quality Management Lead at ZS Associates. She helps clients build and evolve their risk management capabilities, including RBQM, RBM, centralised monitoring and inspection readiness. She has almost 20 years of leadership experience in pharma across R&D. Vera joined consulting after leading RBM at BMS. Prior to that, she spent most of her career at Novartis in clinical data, analytics, training and other strategic initiatives. Vera has had multiple articles published in pharmaceutical magazines and is heavily involved in industry advisory and collaboration groups.